The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study

This study has been completed.
Sponsor:
Information provided by:
Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier:
NCT00821067
First received: January 9, 2009
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance high-energy phosphates and improve function following ischemia, states of congestive heart failure, and recently in subjects with lung disease. An initial preliminary, open label pilot study demonstrated a positive benefit of D-ribose in "Baby-Boomer" subjects aged 50 to 65 years old complaining of persistent fatigue. The objective of this study will build on the previously collected data to evaluate oral D-ribose vs. dextrose (administered as a supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state of fatigue.


Condition Intervention
Fatigue
Dietary Supplement: D-ribose
Dietary Supplement: Dextrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study

Resource links provided by NLM:


Further study details as provided by Bioenergy Life Science, Inc.:

Primary Outcome Measures:
  • CPX parameters relative to placebo as measured by: [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • VO2 at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Ventilation Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Oxygen Uptake Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Heart rate to METS ratio at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
  • Net Energy Expenditure at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
A 6 gm/day (3 gm/bid) dose of D-ribose
Dietary Supplement: D-ribose
A 6 gm/day (3 gm/bid) dose of D-ribose in water. Each subject will consume oral D-ribose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
Placebo Comparator: 2
A 6 gm/day (3 gm/bid) dose of dextrose.
Dietary Supplement: Dextrose
A 6 gm/day (3 gm/bid) dose of dextrose in water. Each subject will consume oral dextrose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presents with complaint of fatigue with duration longer than one month
  • Males/Females between the ages of 50 and 65 years of age
  • No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history
  • Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods
  • Normal blood pressure or those with mild, untreated pre-hypertension (>120/70 or < 140/90 mmHg)
  • Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires
  • Must be able to understand the consent form, agree to participate, and to execute their signature

Exclusion Criteria:

  • Not presently taking any adenine nucleotide enhancing supplements
  • History of non-compliance in previous studies
  • Known to be pregnant
  • Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics
  • Moderate to severe gout
  • A diagnosis of arthritis of the lower extremities
  • Mental impairment, inability to cooperate
  • History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)
  • Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance
  • Any person who is incarcerated, or on a work release program

Additional Exclusions observed and sequelae during initial baseline evaluation:

  • Drop in systolic blood pressure of >10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia
  • Moderately severe angina
  • Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
  • Signs of poor perfusion (cyanosis or pallor)
  • Technical difficulties monitoring the ECG or systolic blood pressure
  • Subject's desire to stop
  • Sustained ventricular tachycardia
  • Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821067

Locations
United States, Colorado
Aurora Denver Cardiology Association
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Bioenergy Life Science, Inc.
  More Information

No publications provided

Responsible Party: Jeff Thompson, Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier: NCT00821067     History of Changes
Other Study ID Numbers: FS20081121
Study First Received: January 9, 2009
Last Updated: December 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014